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Add:No.5 of Minyi Road, Wusha, Changan Town, Dongguan, Guangdong, China

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Medical Devices Parts Method Of Implementing Reliability Index

The trend in the miniaturization of the Medical Devices Parts is leading the manufacturer of medical moldings to make significant changes to itself, changing to measuring the product in tenths of a millimeter. When manufacturers of medical devices want to offer smaller medical devices and implantable devices in new applications, such as drug delivery devices, moldmakers can provide them with smaller, smoother, lighter molding part.

Over the years, medical devices have become smaller and smaller, small implantable devices in the implant process to make patients feel more comfortable, less damage to the body. To meet the demand for small hybrid components for implantable medical devices, we continually improve the layout and packaging technology of microcontrollers (MCUs) - or application specific integrated circuits (ASICs) - and power systems. This article discusses the selection process of passive components in order to reduce the mixing of components and circuit board space in medical devices.

Medical Devices Parts as a modern science and technology products, with the rapid development of medical diagnosis and treatment technology, has been widely used in disease prevention, diagnosis, treatment, health care and rehabilitation, whether high-end or low-end products, its reliability Is the core of the focus. From the thermometer, disposable infusion to the monitor, ventilator, from the pacemaker, artificial blood vessels to the vascular stent, artificial joints, the hospital most of the medical work requires Medical Devices Parts assistance. Not only that, many medical devices will be temporary or long-term implantation of the human body, for medical personnel, the reliability of Medical Devices Parts is impossible to avoid.

Medical Devices Parts reliability engineering is to meet the reliability requirements of medical devices and their parts and components for the reliability of design, testing, production and management of a series of work, through a medical device design, production, testing, packaging, Storage, use, maintenance of all aspects, is a system engineering. One of the most important part of the design. On the one hand, in the design aspects to solve the reliability problem, the lowest cost, the smallest loss; the other hand, in recent years, the injury events more reveal, if the design is unreasonable, alone through training, warning, after the correction It is almost impossible to achieve the expected reliability index.

Therefore, engaged in medical device design and R & D personnel must fully understand and master the theory and method of reliability research, so that developed products with clear and effective reliability indicators, the design can be carried out by the expected, the test can be carried out Testing, the production can be carried out to ensure the process and results, the performance of medical devices in use can be stable and can be controlled throughout the product life cycle. This needs to be based on the reliability research, the medical device design, testing, manufacturing and use process control in a reliability-based management system, through the rational use of management technology, and ultimately achieve the reliability objectives, to protect the public use Safe and effective.

Medical Devices Parts manufacturing enterprises in accordance with the needs of medical activities, clearly put forward the reliability of Medical Devices Parts requirements. At the same time enterprises in the study of Medical Devices Parts reliability requirements, to fully take into account the existing Medical Devices Parts reliability status, the level of existing technology, cost, function, the use of the environment and other factors. Medical device reliability design of the main contents include: to achieve reliability indicators of the methods, ways and organizational measures. Production companies need to develop appropriate implementation plans, quality control plans, reliability verification pilot plans, personnel training programs and reliability data management plan, and have to check the implementation of the program means.

The use of Medical Devices Parts, including the storage, transportation, regular inspection, the use of the preparatory work, according to the provisions of the use and maintenance activities. The basic task at this stage is to maintain the reliability of the medical device and to improve the maintainability and safety of the medical device. It should be noted that the reliability of medical devices is designed, produced, managed out. In the whole life cycle of a medical device, there are two parallel processes of reliability engineering activities: one is the engineering process. In the product design and development stage, through reliability design and design improvements, improve the inherent reliability of medical device products; the other is the reliability of management. In the production stage, the use of various quality tools to reduce the production parameters generated when the variation, control product quality, product development in the design phase to achieve the reliability; in the use of the product, the effective management and maintenance of products to maintain the inherent product reliability.


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Dong Guan FCE Precision Electronics Co.,Ltd

Address: No.5 of Minyi Rd, Wusha, Changan Town, Dongguan, Guangdong, China

Tel: +49(0)17685399327

Fax: 0769-81582880

E-mail: hanna@fcejmdg.com

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